A NIS of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer in Argentina and Brazil -LATAM AVENUE
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 19
- 试验地点
- 7
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This ambispective (both retrospective and prospective) NIS will evaluate the effectiveness and safety of Avelumab as a maintenance therapy administered after completion of first-line platinum-based chemotherapy in patients with locally advanced or metastatic urothelial cancer under routine conditions of daily clinical practice in Argentina and Brazil in line with the approved Avelumab label indication. Primary objective: • To evaluate overall survival (OS) rate at 12 and 24- months after the index date (date of the first Avelumab administration) in patients treated with Avelumab maintenance therapy. Secondary objectives: • To assess OS in patients treated with Avelumab maintenance therapy. To assess progression-free survival (PFS) of patients treated with Avelumab maintenance therapy. • To evaluate safety and tolerability of Avelumab maintenance therapy. • To assess duration of treatment (DOT) between the first and last dose of avelumab. • To describe the clinical and demographics characteristics of Argentinean and Brazilian patients treated with Avelumab maintenance therapy. Other objectives: • To evaluate anti-tumor effectiveness of Avelumab maintenance therapy.
详细描述
Urothelial carcinoma are tumors originating from the urothelial cells that line the bladder, renal pelvis, ureter, and urethra. Each year, bladder cancer (BC) accounts for 3.0% of global cancer diagnoses, with more than 570,000 new cases diagnosed and 2.1% of new deaths, with more than 210,000 deaths worldwide. In Latin America, BC placed the 10th and 9th positions in the incidence of cancer in Argentina and Brazil, respectively, and both countries have BC as the 5th most frequent cancers among males excluding non-melanoma skin cancer. 2-4 Among men, BC is the 6th most common cancer and the 9th leading cause of cancer death. Incidence and mortality in males are approximately four times higher compared to women with BC globally. In 2020, Argentina and Brazil reported over 3,700 and 15,800 new cases of BC, respectively. The 5-year prevalence at all ages of 11,401 (25 per 100,000) in Argentina and 43,545 (20 per 100,000) in Brazil. Besides male population, other risk factors for BC include prevalence of tobacco smoking, infection with Schistosoma haematobium, occupational exposures to organic solvents, and arsenic contamination in drinking water. 2,5 First-line standard of care for patients with advanced or metastatic urothelial cancer is a platinum-based chemotherapy regimen; however, the median OS in patients treated with Cisplatin-based chemotherapy is only 12-14 months, approximately. Besides, most patients with advanced or metastatic urothelial cancer commonly experience disease progression within 9 months after initiation of treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, ≥18- years of age at the time of Avelumab treatment initiation
- •Patients with locally advanced or metastatic urothelial cancer with any histology (histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma and/or documented Stage IV disease (per American Joint Committee on Cancer/International Union for Cancer Control TNM system1 19-21) at the start of first-line chemotherapy)
- •Patients who have completed first-line platinum-based chemotherapy with no evidence of disease progression according to medical chart (ie, with a SD, PRor complete response [CR]).
- •Patients who are receiving or have received at least one dose of Avelumab as the firstl ine maintenance therapy according to label indication
- •Patients with ongoing treatment with Avelumab who provided written informed consent allowing the data collection. For decease patients and those who are lost to follow-up, an approved ICF waiver is allowed.
排除标准
- •Patients who have participated in any interventional clinical trial of a drug or device within 28- days prior to the start of Avelumab maintenance therapy.
研究组 & 干预措施
Patients with Advanced or Metastatic Urothelial Cancer
Patients with Advanced or Metastatic Urothelial Cancer
干预措施: Avelumab (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 36 months
To evaluate OS rate at 12- and 24- months after the index date (date of the first Avelumab administration) in patients treated with Avelumab maintenance therapy.
次要结局
- Progression-Free Survival(36 months)
- Frequency of all-cause AEs leading to discontinuation or interruption of Avelumab maintenance therapy(36 months)
- OS(36 months)
- Frequency of patients with Avelumab dosing change due to any AE related to this drug(36 months)
- Duration Of Treatment(36 months)
- Frequency and nature of all-cause adverse events (AEs)(36 months)
- Duration of Avelumab maintenance therapy among the patients who discontinued the study drug due to all-cause AEs(36 months)
- Frequency of potential signs and symptoms of immune-related AEs(36 months)